AccessGUDID - DEVICE: Multi-Analyte DAU Calibrator Set E, High Calibrator (B07608950)

GUDID

Device Identifier (DI) Information

Brand Name: Multi-Analyte DAU Calibrator Set E, High Calibrator
Version or Model: 0895
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0895
Company Name: LIN-ZHI INTERNATIONAL, INC.

Primary DI Number: B07608950
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 840839190 *Terms of Use

Device Description: 15 mL/bottle. Concentration of Multi-Analyte: 1000 ng/mL secobarbital, 40 ng/mL norbuprenorphine, 1000 ng/mL methadone, and 100 ng/mL phencyclidine.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
55460	Multiple drugs of abuse IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of one or multiple drugs of abuse in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DKB	Calibrators, Drug Mixture

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 59cec0f8-f009-455a-a9bd-8b1906d869dc
Public Version Date: April 03, 2019
Public Version Number: 1
DI Record Publish Date: March 26, 2019